Adamis Pharmaceuticals has announced that a clinical study comparing its APC-2000 albuterol MDI with GSK’s Ventolin Evohaler MDI met its primary endpoint, showing equivalence in change from baseline of FEV1 for both doses tested (100 and 200 mcg).
The company said that the study, which involved 124 patients with mild to moderate asthma, took place “outside of the United States” and was in line with the 2013 FDA draft guidance on albuterol sulfate.
The Adamis website currently makes no mention of APC-2000, nor does a January 9, 2015 prospectus for an offering of 2,000,000 shares of common stock. According to a company spokesperson, Adamis has refocused its attention on the albuterol MDI within the past month.
Adamis President and CEO Dennis J. Carlo commented, “Based on the study conclusions, we predict that our drug (APC-2000) will be as safe and efficacious as Ventolin. We expect that this will be confirmed in an upcoming Phase 3 study in which we will compare APC-2000 and Ventolin for non-inferiority.”
Earlier this year, the company announced positive results from a Phase 1 study of its APC 5000 fluticasone/salmeterol DPI. That product uses the 3M Drug Delivery Systems Taper device, which Adamis licensed from 3MDDS in 2013.
Read the Adamis press release.
